Tanta University
Tanta, El-Gharbia, 31527, Egypt
NCT Number: NCT06562712
This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum.
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Tanta, El-Gharbia, 31527, Egypt
Placenta accreta spectrum (PAS) is abnormal placental adhesion beyond superficial myometrium, which includes placenta accreta, placenta increta, and placenta percreta.
However, there is a desire to preserve the uterus and fertility, so alternatives to hysterectomy are needed. Presently, attempts to avoid hysterectomy include reducing intraoperative hemorrhage such as uterine compression sutures, intrauterine balloon tamponade, pelvic artery ligation, and spiral suturing of the lower uterine segment. Intrauterine balloon tamponade may increase CS scar dehiscence, uterine rupture, and infection. Combined with compression sutures, it may induce uterine necrosis.
Placement of balloons in the bilateral internal iliac arteries before caesarean section can reduce uterine artery pressure and intraoperative blood loss during balloon inflation, thus temporarily blocking the main blood supply of the uterus, helping to expose the visual field, shortening the operation time during surgery, and leading to opportunities for timely adjustments to the operative plan during surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be subjected to conventional management for placenta accreta spectrum.
Patients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum.
Time frame: Intraoperatively
The amount of intraoperative blood loss will be calculated with reference to the contents of the suction apparatus and to weight of the surgical pads and the hemoglobin concentration difference, immediate preoperative (the morning of cesarean delivery) and postoperative (immediately after cesarean delivery) hemoglobin levels.
Time frame: From the start till the end of surgery
Operation time will be recorded from start till end of surgery.
Time frame: 24 hours postoperatively
Number of blood products units transfused will be recorded.
Time frame: 28 days postoperatively
Hospitalization length will be recorded from admission till discharge from hospital.
Time frame: 24 hours postoperatively
Incidence of hysterectomy will be recorded.
Time frame: 24 hours postoperatively
Intensive Care Unit (ICU) admission rate will be recorded.
Time frame: Intraoperatively
Intraoperative complications such as bladder injury, ureteric ligature, and uterine atony will be recorded.
Tanta University
Other
Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management: A Randomized Controlled Trial
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